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3-Part Study With 2 6-Period Single Dose Parts (Pt 1, Pt 2 Optional) Followed by a 1-Period Multiple Dose Part (Pt 3) to Evaluate Prototype Modified Release Matrix and Multi Particulate Formulations of Anatabine Citrate to Determine PK

Trial Profile

3-Part Study With 2 6-Period Single Dose Parts (Pt 1, Pt 2 Optional) Followed by a 1-Period Multiple Dose Part (Pt 3) to Evaluate Prototype Modified Release Matrix and Multi Particulate Formulations of Anatabine Citrate to Determine PK

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 Feb 2016

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At a glance

  • Drugs Anatabine (Primary)
  • Indications Alzheimer's disease; Inflammation; Multiple sclerosis; Neurological disorders
  • Focus Pharmacokinetics
  • Sponsors Rock Creek Pharmaceuticals Inc
  • Most Recent Events

    • 03 Feb 2016 Interim report of the pharmacodynamic results of this trial published in a Rock Creek Pharmaceuticals media release.s
    • 19 Oct 2015 Status changed from active, no longer recruiting to completed according to a Rock Creek Pharmaceuticals media release.
    • 10 Aug 2015 According to a Rock Creek Pharmaceuticals Inc. media release, part two of this study will be conducted with a protocol amendment that primarily evaluates the effects of food on PK parameters. The dosing for part two is expected to commence and be completed within the third quarter of 2015. amendment. Part three is expected to be complete along with prelimnary results in the third quarter of 2015.
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